Nationwide Recall, Eye Drops May Cause Infection - MedWaste Management Nationwide Recall, Eye Drops May Cause Infection - MedWaste Management

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Recall Eye Drops

Nationwide Recall, Eye Drops May Cause Infection

The FDA has issued an immediate recall of multiple lots of eyedrops, all manufactured in a facility they found unsanitary. Velocity Pharma, LLC in Dublin, Ohio, manufactures ophthalmic drops for Cardinal Health, Inc. and The Harvard Drug Group, LLC (Major Pharmaceutical/Rugby Laboratories). As of the writing of this notice, the FDA has received three adverse event reports from consumers who experienced vision blurriness, vision loss, and burning eyes. Upon inspection, the FDA’s environmental testing results were positive for the presence of bacteria.

 SUMMARY

Date of Recall:

Announced: October 31, 2023

Public Notification: November 1, 2023

Name(s) of Drug:

Multiple eye drops named

See below

Company Name:

The Harvard Drug Group, LLC

Major Pharmaceutical

Rugby Laboratories

Cardinal Health, Inc.

LEADER

Drug Indication:

Dry Eyes

Eye Irritation

Recall Eye Drops Recall Eye Drops

Product Description

The eye drops are packaged in 0.33oz and 0.5oz bottles, and packaged in a box labeled with brand information. Wholesale and retail pharmacy locations nationwide and online distributed the over-the-counter nasal sprays.

Reason for Recall

After receiving several adverse event reports from consumers, the FDA inspected the manufacturing facility and found it to be unsanitary. Bacterial testing was positive, indicating that the eye drops may contain harmful pathogens that can cause eye infections.

Impacts

Consumers who continue to use the contaminated eye drops are at risk of developing eye infections. These infections can lead to pain or loss of sight and may spread throughout the body, leading to death.

Lot Information

Consumers who use eye drops should check the listing below against the information on their eye drop packaging. If the information matches, read further to determine what actions must be taken to participate in the recall.

Brand Name
Product Name
Package Description
NDC

Rugby®

Polyvinyl Alcohol, 1.4% Lubricating Eye Drops 0.5oz Bottle (15mL) 0536-1325-94

Rugby®

Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) 0.5oz Bottle (15mL)

0536-1282-94

Leader™

Eye Irritation Relief (Polyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline Hydrochloride 0.05%) 0.5oz Bottle (15mL)

70000-0087-1

Leader™

Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) 0.5oz Bottle (15mL)

70000-0089-1

Leader™ Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) 0.5oz Bottle (15mL)

70000-0090-1

Leader™

Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) 2 Bottles, 0.5oz Bottle (15mL) Each

70000-0090-2 (Carton) 70000-0090-1 (Bottle)

 

Leader™ Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%) 0.33oz Bottle (10mL)

70000-0088-1

Leader™ Lubricant Eye Drops (Propylene Glycol, 0.6%) 0.33oz Bottle (10mL)

70000-0587-1

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

  1. Call your doctor right away. Report the use of the recalled medication.
  2. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
  3. Consumers with questions may contact Sedgwick, Inc. by phone at 1-855-215-4940. They are available Mon-Fri from 8:00 a.m. to 5:00 p.m. (EST). You can also contact them via email at Cardinalhealth7720@sedgwick.com or harvarddrug8430@sedgwick.com.
  4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Sedgwick, Inc. by phone at 1-855-215-4940 or utilize Cardinalhealth7720@sedgwick.com or harvarddrug8430@sedgwick.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Sedgwick, Inc. by phone at 1-855-215-4940 or utilize Cardinalhealth7720@sedgwick.com or harvarddrug8430@sedgwick.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

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Tammy McKinney, Nurse Writer

 

 

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!

 


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